Comparison of oxycodone pharmacokinetics after buccal and sublingual administration in children

Abstract

Objective: We evaluated and compared the pharmacokinetics of two oral administration routes of oxycodone parenteral liquid (10 mg/mL)--single buccal and sublingual administration--in 30 generally healthy awake children, aged 6-91 months.

Methods: Two groups of children undergoing inpatient surgery were enrolled. In a randomised fashion, children received a single dose of oxycodone 0.2 mg/kg buccally (n = 15) or sublingually (n = 15). Regular blood samples were collected for up to 12 hours, and plasma was analysed for oxycodone, oxymorphone and noroxycodone using gas chromatography-mass spectrometry.

Results: Bioavailability was similar after administration at the two instillation sites. The area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinfinity) was 2400-8000 ng x min/mL (median 4200 ng x min/mL) in the buccal group and 2700-7900 ng x min/mL (median 5500 ng x min/mL) in the sublingual group. After buccal administration, maximum plasma concentration (Cmax) was 5.4-39 ng/mL (16 ng/mL) after buccal and 5.5-42 ng/mL (22 ng/mL) after sublingual administration. Twelve of the 15 children in both groups reached the oxycodone analgesic concentration of 12 ng/mL, which was sustained for 43-209 minutes (median 160 minutes) in the children with buccal oxycodone and for 32-262 minutes (median 175 minutes) in the children with sublingual oxycodone. The terminal elimination half-lives were closely similar in the two groups: 104-251 minutes (median 140 minutes) in the buccal group and 110-190 minutes (150 minutes) in the sublingual group.

Conclusion: The results of this study show that in young children the absorption of oxycodone is similar after buccal and sublingual instillation.